Court rules in FDA’s favor against stem cell clinic

July 8, 2019

A federal court has agreed with the Food and Drug Administration that a Florida clinic adulterated and misbranded a stem cell drug product made from a patient’s fat tissue.

The summary judgment against US Stem Cell Clinic, US Stem Cell and the company’s chief medical officer affirms the FDA’s regenerative medicine policy and its risk-based approach to the enforcement of cell-based products. US Stem Cell has agreed for now to stop producing and administering treatments from adipose tissue.

The FDA also has sought a permanent injunction against a California-based company, seeking to stop it from selling unapproved cellular therapy products.

The stories were reported in multiple national outlets, including the Los Angeles Times, and The New York Times.

“The FDA is playing hardball with these clinics in Florida and California and the federal court just backed them up,” said Scott Jones, Vice President, Scientific Affairs, at BioBridge Global. “The FDA is aggressively taking steps to bring clinics, companies and individuals manufacturing stem cell products, with known or potential violations, into compliance via warning letters and permanent injunctions.”

GenCure, a subsidiary of BioBridge Global, only works with stem cell researchers seeking approval for therapies through the FDA.

Dr. Mark Knoepfler, a stem cell researcher at the University of California Davis, noted the finding in the Florida case may be applied to a larger organization.

“It’s now almost a sure bet that the big fat stem cell clinic chain Cell Surgical Network and its co-defendants in the other major federal lawsuit by the FDA will also lose,” Knoepfler wrote after the Florida decision was announced. “The main elements of that still pending case are almost identical to the (US Stem Cell) case.”

The FDA first issued a warning letter to US Stem Cell in 2017 for, as the FDA noted in a news release, marketing stem cell products without FDA approval and “significant deviations” from current good manufacturing practice requirements.

“The FDA has not approved any biological products manufactured by US Stem Cell Clinic for any use,” the agency’s release said.

“It’s good to see the FDA is not going to tolerate clinics marketing stem cell products without FDA approval,” Jones said. “These unlicensed treatments can be very damaging to patients. Products from US Stem Cell were described in an article in the New England Journal of Medicine to have caused blindness or bad vision impairment in three female patients with age-related macular degeneration.”

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